| Primary Device ID | 08800070236833 |
| NIH Device Record Key | 9117932e-5649-418e-9a59-71a420295441 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bite Impression Coping Driver |
| Version Model Number | BICD40SS |
| Company DUNS | 963328442 |
| Company Name | Izenimplant Co., Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800070236833 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800070236833]
Moist Heat or Steam Sterilization
[08800070236833]
Moist Heat or Steam Sterilization
[08800070236833]
Moist Heat or Steam Sterilization
[08800070236833]
Moist Heat or Steam Sterilization
[08800070236833]
Moist Heat or Steam Sterilization
[08800070236833]
Moist Heat or Steam Sterilization
[08800070236833]
Moist Heat or Steam Sterilization
[08800070236833]
Moist Heat or Steam Sterilization
[08800070236833]
Moist Heat or Steam Sterilization
[08800070236833]
Moist Heat or Steam Sterilization
[08800070236833]
Moist Heat or Steam Sterilization
[08800070236833]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-20 |
| Device Publish Date | 2024-12-12 |
| 08800070235065 | BICD5014S |
| 08800070235003 | BICD5018L |
| 08800070234945 | BICD4014S |
| 08800070234877 | BICD4018L |
| 08800070236864 | BICD50LS |
| 08800070236857 | BICD50SS |
| 08800070236840 | BICD40LS |
| 08800070236833 | BICD40SS |